Systems and methods for removing undesirable material within a circulatory system

A system for removing an undesirable material from a treatment site within a vasculature of a patient, the system comprising:

• a suction cannula comprising a lumen and a distal end, and an expandable funnel coupled to the distal end of the suction cannula and configured to be positioned adjacent to the treatment site, the expandable funnel comprising a unitary metallic reinforcement structure and a polymer wall, the unitary metallic reinforcement structure comprising a metallic proximal end configured to be directly connected to the distal end of the suction cannula and a metallic expansion section extending from the metallic proximal end, the metallic expansion section comprising a nitinol material and being configured to automatically expand the expandable funnel when released from constraint of an outer sheath, to resist collapse from a user-controlled suction force applied through the cannula lumen and the expandable funnel, and to permit radial compression of the expandable funnel when retracted into the outer sheath;
• a filter device in fluid communication with the cannula lumen, the filter device comprising a filter membrane being configured to capture the undesirable material while permitting filtered blood to pass therethrough;
• a reservoir in fluid communication with the filter device and configured to transiently collect the filtered blood;
• a pump configured to generate a user-controlled suction force through the suction cannula and to move blood and undesirable material from the treatment site through the filter device such that filtered blood is moved to the reservoir;
• and
• a reinfusion assembly configured to reinfuse the filtered blood into the vasculature.

A catheter system for removing a pulmonary embolism from a treatment site within a pulmonary artery, the catheter system comprising:

• a steerable outer sheath comprising a lumen, an inner polymer wall, an outer polymer wall, and a reinforcement element positioned between the inner polymer wall and the outer polymer wall, the reinforcement element being configured to provide sufficient rigidity and torqueability to aid in manual navigation of the steerable outer sheath across a heart valve, through a heart chamber, and into the pulmonary artery near the treatment site;
• an aspiration cannula comprising a cannula lumen and a distal end, the aspiration cannula being configured to be coaxially positioned within the lumen of the steerable outer sheath and to be axially movable relative to the steerable outer sheath;
• and
• a funnel comprising a polymer wall and a unitary metallic reinforcement frame, the unitary metallic reinforcement frame comprising a metallic proximal end and a single-piece metallic expansion section extending from the metallic proximal end, the metallic proximal end being configured positioned at the distal end of the aspiration cannula, the metallic expansion section comprising a shape-memory metallic material configured as a self-expanding structure and pre-shaped in an expanded configuration;
• wherein, when the funnel is released from constraint by the steerable outer sheath, the single-piece metallic expansion section automatically expands the funnel from a collapsed configuration to an expanded configuration;
• wherein, when the funnel is in the expanded configuration, the single-piece metallic expansion section resists collapse under an applied vacuum sufficient to aspirate at least a portion of the pulmonary embolism through the cannula lumen;
• and
• wherein, as the funnel is withdrawn into the lumen of the steerable outer sheath, the single-piece metallic expansion section permits radial compression of the funnel from the expanded configuration to the collapsed configuration.

A device for removal of an undesirable material from within a vasculature, the device comprising:

• an aspiration cannula comprising a cannula lumen and a cannula distal end;
• an expandable funnel extending from the cannula distal end, the expandable funnel comprising an impermeable polymeric membrane and a unitary metallic reinforcement structure comprising a metallic proximal end extending from the cannula distal end and a pre-shaped metallic expansion section extending from the metallic proximal end, the pre-shaped metallic expansion section being formed from a shape-memory metallic material;
• wherein the pre-shaped metallic expansion section is configured, in an expanded configuration, to self-expand the expandable funnel to a funnel shape when released from constraint of an outer sheath and to resist collapse under an aspiration force sufficient to aspirate at least a portion of the undesirable material through the cannula lumen;
• wherein the pre-shaped metallic expansion section is further configured, in a collapsed configuration, to permit radial compression of the expandable funnel into a lumen of the outer sheath and to be stackable during the radial compression of the expandable funnel;
• wherein a distal portion of the pre-shaped metallic expansion section is substantially rounded;
• wherein a distal-most portion of the impermeable polymeric membrane extends a selected distance distally beyond a distal-most end of the pre-shaped metallic expansion section to provide an atraumatic distal end of the expandable funnel.